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Significant events during the third quarter
· Abstract was presented at San Antonio Breast Cancer Symposium
· New office and staff in USA
Significant events after the end of the period
· Abstract to be presented at AACR in April
· Shares now traded on Nasdaq First North Premier
· Lars Holmqvist elected as new Chairman
· Two new customers, a pharmaceutical company and a CRO, and sales of SEK 1.5
million.
CEO’s comments
Continued focus on commercialization of DiviTum®
The focus of Biovica’s business plan is commercialization of DiviTum®, which
will provide cancer patients with more personalized treatments leading to better
outcomes while ensuring that society uses it resources in the most efficient
way. We have targeted the US and European market, where Biovica’s market
potential for DiviTum® is estimated at SEK 6 billion.
We took significant steps towards that goal in the third quarter:
· Progress in the efforts aimed at FDA approval in accordance with plan
· Additional positive study results that provide the foundation for
commercialization of DiviTum®
· New employees fortify the organization for the pending commercialization
Progress in our efforts to obtain FDA approval
Biovica has concluded the development project for the product to meet the
requirements for FDA approval. These improvements are currently being verified
in accordance with the agreed specification with the FDA in the supplement 1
stage.
Additional positive study results
Our clinical development program documents the benefits of DiviTum® to both
patients and society. It also provides the foundation for successful
commercialization of the product. The study results are a necessary component of
the regulatory process and for obtaining reimbursement. They are also very
important in generating demand and for establishing commercial partnerships for
sales.
We are thus very pleased with the study results we received in February 2019
showing that DiviTum®, as the first blood-based biomarker, can be used to
evaluate the effects on metastatic breast cancer following treatment with
Palbociclib (a CDK4/6 inhibitor). The results will be presented at the AACR
Annual Congress in April 2019.
Fortified organization as we prepare for commercialization
Biovica held an extraordinary general meeting on 20 March 2019 to elect Lars
Holmqvist as the company’s new Chairman of the Board. Lars Holmqvist will
contribute his unique expertise of the commercialization process. He also has an
extensive international network that will be of great value to Biovica during
the ongoing commercialization process for DiviTum®. Lars replaces Göran Brorson,
who has made a valuable contribution to Biovica and was a driving force in its
development.
Biovica also established an office and staff in Boston, USA. It is another
important part of the ongoing commercialization process, bringing us closer to
both partners and customers.
New customers and sales of SEK 1.5 million
The great potential for the product exists in the market for clinical use, which
requires regulatory approval. Additional potential for DiviTum® exists in the
research market, where the test is used to help develop new cancer drugs. Two
new customers, a pharmaceutical company and a CRO, haves been added and they''ve
also placed their first orders. Their orders for the DiviTum® kit total
approximately SEK 1.5 million. Two global pharmaceutical companies that develop
new cancer drugs and see the benefits of DiviTum® are behind these orders.
Future
Biovica has a unique product that fulfills a great need in the market. We are
following our plan for product launch. We have obtained good results from our
studies with DiviTum® and our interaction with the FDA has been positive. On the
whole, I am optimistic about the future and confident that the day is
approaching when we can feel proud of having contributed the best possible
treatment from day one to cancer patients all over the world, while creating
great significant value to our shareholders.
Anders Rylander
CEO
More information:
Anders Rylander, CEO Biovica.
Phone: +46 (0)18 444 48 35,
E-mail: anders.rylander@biovica.com
Cecilia Driving, CFO
Phone +46 (0)73 125 92 47
Email: cecilia.driving@biovica.com
The information was submitted for publication, through the agency of the contact
person set out above, at 08:00 pm CET on March 21, 2019.
In the event of contradictions or differences between the Swedish press release
and this English version the Swedish text will prevail.
About Biovica
Biovica develops and commercializes blood-based biomarker assays that improve
monitoring of modern cancer therapies and predict patient outcome. The company’s
DiviTum® assay, a test for accurately measuring cell proliferation, has
successfully demonstrated its capabilities to early evaluate therapy
effectiveness in several clinical trials. Biovica aims to make best-possible
-treatment from day one a reality.
Biovica collaborates with world-leading cancer institutes as well as
pharmaceutical companies launching next-generation therapies. The company is ISO
13485 certified for Quality Management Systems. DiviTum® is CE-labeled and MPA
-registered. Appointed Certified Adviser to the company is FNCA Sweden AB,
info@fnca.se, +46 8 528 00 399.
Read more: www.biovica.com |